Washington Editor

WASHINGTON - The FDA's plan to speed the biologics review process by consolidating certain functions of the center for biologics with the center for drugs goes into effect today.

FDA Deputy Commissioner Lester Crawford, who headed the FDA before current commissioner Mark McClellan was appointed, announced the consolidation plan last summer, billing it as a move toward producing a more efficient, effective and consistent review program for human drugs and biologics. (See BioWorld Today, Sept. 9, 2002.)

The move will not eliminate the Center for Biologics Evaluation and Research (CBER), however

Agency officials have been under enormous pressure from the industry as well as Capitol Hill to pick up the pace on the review process.

It's difficult to push biologics license applications through the process swiftly because they are considerably more complex than new drug applications, FDA officials have said.

But the industry is so anxious to get its products to market faster that representatives agreed to pay more money under the reauthorized version of the Prescription Drug User Fee Act (PDUFA III) in order to get better services from the FDA. Under PDUFA III, the FDA agreed to allow companies to bring in an independent consultant to help with certain cutting-edge science and to spend $7 million over five years to pay for initiatives aimed at improving the review process. (See BioWorld Today, May 23, 2002.)

And since McClellan came on board as commissioner, the agency started looking at ways of updating its services, procedures and policies. In fact, over the past six months, the FDA often has been described as "improved" or "friendly."

When asked whether drugs and biologics appear to be making it through more quickly, Alvin Lorman, a partner with Foley & Lardner's law office in Washington, said there's a perception that there's been an increase in the pace of approvals. "On the other hand, you also need to remember that sometimes these are statistical artifacts because last year there was an apparent decrease, so we may be catching up a little," he said.

"But I think there's no question that the commissioner and this administration have committed to trying to improve the management process. We're not talking about changing the scientific standards, it's just that they are trying to change the management process so that these things get processed more efficiently," Lorman said.

Indeed, any company impacted by the consolidation likely has been contacted by the agency via mail.

Product classes that will be transferred from CBER to the Center for Drug Evaluation and Research (CDER) are the following:

  • Monoclonal antibodies for in vivo use;

  • Cytokines, growth factors, enzymes, immunomodulators and thrombolytics;

  • Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of those products (except clot- ting factors);

  • Other nonvaccine therapeutic immunotherapies.

The following classes will remain at CBER:

  • Viral-vectored gene insertions (gene therapy);

  • Products composed of human or animal cells or from physical parts of those cells;

  • Allergen patch tests;

  • Allergenics;

  • Antitoxins, antivenins and venoms;

  • In vitro diagnostics;

  • Vaccines, including therapeutics vaccines;

  • Toxoids and toxins intended for immunization;

  • Blood, blood components and related products.